Trial of Methyl Aminolevulinate Plus Aktilite in Facial Photodamage

Phase 3

Completed

• Conditions: Skin Aging
• Interventions: Drug: Methyl Aminolevulinate; Other: Moisturizer

• Registration Number: NCT00629317
• Lead Sponsor: Universidad de Antioquia

Brief Summary

The aim of the study is to determine the efficacy of MAL + Aktilite versus placebo + Aktilite in facial photodamage in a randomized double blind trial.

Detailed Description

It has been demonstrated that photodamage leads to wrinkles, mottled pigmentation, lentigines, telangiectasias, and textural changes, but more importantly, it can also lead to pre-cancerous conditions with the development of actinic keratosis (AK). The majority of photorejuvenation or photodamaged published studies have used 5-Amino-Levulinic acid (5-ALA) as a photosensitizer, and either a blue light or an Intense Pulsed Light source with a 70%-95% global facial skin improvement. The molecular mechanism of such improvement is unknown, but activation of a non-specific immune response in addition to increased fibrosis and new collagen formation, have both been suggested.

Methyl Aminolevulinate ( MAL) is another marketed photosensitizer mainly utilized in Europe. Lipophilicity, higher penetration depth and tumor selectivity has been advocated for MAL compared to 5-ALA. However, its effect in photodamaged skin has not been well documented.

The aim of the study is to determine the efficacy of MAL + Aktilite (PDT) in facial photodamage.

Study Type: Interventional

Study Design: Randomized, double-Blind, placebo-controlled trial. Official Title: A randomized, double-Blind, placebo-controlled trial of Methyl Aminolevulinate + Aktilite in patients with facial photodamage.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-25
• Study First Submitted QC: 2008-03-04
• Study First Posted: 2008-03-06
• Primary Completion: 2009-01
• Status Verified: 2009-03
• Study Completion: 2009-03
• Last Update Submitted: 2009-03-13
• Last Update Posted: 2009-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 49

Inclusion Criteria

• Female subjects older than 35 years of age and less than 75 years of age
• Subjects with a photodamage grade of 2 or 3 according to a modified Dover´s Global photodamage scale
• Subjects willing to participate according to protocol requirements.
• Patients with signed Informed Consent
• Patients with no exclusion criteria

Exclusion Criteria

• Pregnant or nursing females.
• Subjects with suspected porphyria, Systemic or cutaneous erythematosus lupus, or any other photosensitizing disorder or drug induced photosensitization.
• Any active infectious skin disorder ( Herpes simplex, molluscum contagiosum, facial warts )
• Subjects with less than 6 months of previous rejuvenation interfering treatments
• Subjects requiring concurrent treatment that would interfere with study objectives and/or assessments.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Methyl Aminolevulinate	-
B	Moisturizer	-

Primary Outcome Measures

Name	Time	Method
Efficacy in facial global photodamage	8 months

Secondary Outcome Measures

Name	Time	Method
Facial fine lines, mottled pigmentation, tactile roughness, sallowness, erythema, telangiectasia	12 months
Histological effect of MAL+PDT in fibrosis and new collagen formation	12 months
Safety and tolerance	12 months

Trial Locations

Locations (1)

IPS Universitaria - Universidad de Antioquia; 🇨🇴 Medellin, Antioquia, Colombia